Class II · ModerateRecall completed
Nevirapine Extended Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: GG80257, Exp. 12/2019
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byCipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156 foreign manufacturer
| Distributed by / for | Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156 |
| NDC | 69097-403-02 |
Show the full FDA record
| Full product label | Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02 |
| Recalling firm | Cipla Limited |
| Distribution | Nationwide within the United States |
| Quantity | 4800 bottles |
| Recall initiated | 2018-12-14 |
| Report date | 2018-12-26 |
| Recall completed | 2020-07-08 |
| Recall number | D-0382-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Vasco Da Gama India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.